Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes

Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes: An Experimental Evaluation of the Family Centered Empowerment Model

Empowerment in healthcare, particularly in the context of chronic illness management such as diabetes, entails equipping patients with knowledge, expertise, and self-assurance to proactively oversee their health and make well-informed choices. This encompasses comprehensive strategies that target psychological, social, and lifestyle elements with the goal of enhancing self-confidence and health results. The objective of this research is to evaluate how the Family-Centered Empowerment Model affects the clinical and psychological outcomes of adolescents with Type 1 Diabetes, with an emphasis on increases in quality of life, self-efficacy, and glycosylated hemoglobin (HbA1c) levels.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Education program

Detailed Description

Diabetes mellitus (DM) is a prevalent and increasingly acknowledged medical disorder that affects individuals worldwide. It is a metabolic condition marked by elevated blood glucose levels that can cause serious side effects like renal failure, heart disease, blindness, and even amputations. To provide a better understanding of the Family-Centered Empowerment Model intervention applied in this work, the components and delivery modes are described in more detail below. Furthermore, a figure or a table suggested at this part could help to present this information more shortly. Details about the intervention The Family-Centered Empowerment Model intervention aimed to help engage the adolescent, an individual with type 1 DM, and his/her family in the self management process. The purpose of this study was to improve coping skills with type 1 DM population by increasing teamwork between adolescents and their members of their household.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Nicosia, Turkey
    • Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals with type 1 diabetes, ages 12 to 18 years
• Patients who had not taken part in any professional diabetes education program within a month of receiving their diagnosis
• Patients who had been diagnosed at least six months earlier to the commencement of the study.

Exclusion Criteria:

• Adolescents who had severe long-term diseases
• Patients newly diagnosed type 1 diabetes.
• those who were enrolled in a diabetes education program one month or less prior to the commencement of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; An official diabetes education program and family empowerment model where employed, designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Types of diabetes, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs	Behavioral: Education program; An official diabetes education program designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Diabetes kinds, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs. Additionally, they offer psychological assistance to help people manage the emotional challenges of having diabetes.; Other Names: Diabetes education program
No Intervention: Control group; Patients diagnosed with type 1 diabetes mellitus for six months or more and had not attended any form of structured diabetes education including hospital-based classes or community group diabetes education classes for the preceding month of the study. These parameters were adopted to ensure that study takes place in a controlled environment and targets the aspects of intervention of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated hemoglobin level	Serum glycosylated hemoglobin level was measured as a baseline, then 6 months after the intervention, to measure the mean difference between the two readings.	6 months
Quality of life	Pediatric Quality of Life-Diabetes Module was used. The twenty-eight items in this multidimensional tool are categorized into five domains: treatment obstacles (four items), treatment adherence (seven items), concern (three items), and diabetic symptoms (eleven items). For teenage self-report, a five-point Likert scale was employed. The total number of questions divided by the total number of answers is how scale scores are calculated.	6 months

Collaborators and Investigators

• Sponsor: Near East University, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Diabetes mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NEU/2023/110-1681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study protocol, methodology, results, and the accompanying data will be published online after peer review process by the scientific journal to which it will be submitted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No